Our SARS-CoV-2 IgM/IgG Antibody Test Kits are single-use rapid immunochromatographic tests for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and venous whole blood (heparin, dipotassium EDTA, and sodium citrate). They are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
INTENDED USE For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection. FEATURES Coated with carefully selected specific Nucleocapsid and Spike protein antigen. Detection for IgM and IgG antibodies simultaneously. Simple operation, easy result interpreted. Rapid test within 15 minutes. RESULTS INTERPRETATION Positive: 1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies. 2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody. 3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody. Negative: 1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative. Invalid: 1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested. 2. The test result is invalid after 15 min. CLINICAL PERFORMANCE - Positive Percent Agreement (PPA) = 91.07% (153/168) (95% CI: 85.70%-94.92%). - Negative Percent Agreement (NPA) = 95.37% (103/108) (95% CI: 89.53%-98.48%). - Overall Rates of Agreement (ORA) = 92.75% [(153+103)/ (168+108)] (95% CI: 89.03%-95.52%). [Product Name]: SARS-CoV-2 IgM/IgG Duo Test [Product Code]: Cat# FP-319 [Sample Type]: Whole blood /Plasma/Serum [Sample Volume]: 20L /10L/10L [Detection Method]: Colloidal Gold [Reaction Time]: 10-15min [Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL. [Storage Condition]: 2oC ~ 30oC [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/499/2021.
SARS-CoV-2 IgG/IgM Rapid Test Kit Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma Product Format: 25 tests/kit Kit Contents: test card, diluent, capillary, lancet, and instruction for use. Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision 100% Concordant across 3 lots with CV ±5% Performance Comparison (A) China Validation Test Positive Samples 100 / 102 Sensitivity: 98.04% Negative Samples 491/492 Specificity: 99.80% Overall Accuracy: 99.49% Performance Comparison (B) Positive Samples 23 / 25 Sensitivity: 92% Negative Samples 25 / 25 Specificity: 100% Overall Accuracy: 96%
SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal swab samples) SARS-CoV-2 Antigen Rapid Test Saliva) We have two fast screening reagents for routine detection. One is the antibody iggigm detection reagent (that is, blood for three minutes) One is antigen rapid screening test reagent (the same is three minutes can use nasal mucosa, oral mucosa, and saliva three detection methods) 1.SARS-CoV-2 antigen testing can detect infection earlier than antibody testing 2.SARS-CoV-2 antigen testing can detect SARS-CoV-2 and all mutant virus strains 3.Easy operation and quick results 4.The result is clear. C-line and T-line determines the infection and the result is easy to read 5.The colloidal gold method has stable performance and is not interfered by environmental and experimental conditions 6.Application: for human throat swab , nasal swab and sputum extract Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains: GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request. To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away. 1. Nasopharyngeal 2. Nasal 3. Saliva Price and Minumum Quantity Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet Sample: Available. Sample Cost Born By Supplier Product Model And Origin Brand: GENEDIAModel: 643G-S (Saliva) Seller Code: Genedia w covid 19 agHS Code: 3002.15 Standards: Ce Competitive Advantages Allow wider testing with fast test time (10 minutes) All necessary materials provided / no equipment needed Sensitivity: 93.33%, specificity: 100% Free sample. no moq. price is negotiable. customized packing. Other Details 20 tests / kit 24 months from the date of manufacture 2 ~ 30c(35.6 ~ 86f) available for room temperature deliver In stock. fast delivery. 1 x Instructions for Use Manual 40 x Test Cassettes 1 x Buffer 40 x Dropper
INTENDED USE For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection. FEATURES Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2. Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva. Easy to use, easy results interpretation by naked eyes. Test result available within 15minutes. TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit. RESULTS INTERPRETATION Positive: A red line appears on the test line (T) and the control line (C). NOTE: A positive result does not rule out co-infections with other pathogens. Negative: Only the control line (C) appears, and no red line appears on the test line (T). NOTE: A negative result does not exclude infection. Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again. CLINICAL PERFORMANCE SARS-CoV-2 Antigen Test Kit Comparator Method (NTA) Positive Negative Total Positive 97 0 97 Negative 3 100 103 Total 100 100 200 - Positive Agreement (95% CI): 97/100 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100 100.0% (95.5% - 100%) - LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen. - Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable. - No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track. - Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%). [Product Name]: SARS-CoV-2 Antigen Test [Product Code]: Cat# FP-318 [Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva [Detection Method]: Colloidal Gold [Reaction Time]: Within 15min [Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1. [Storage Conditions]: 2*C ~ 30*C [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/99/2021.
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TBG SARS-CoV-2 Neutralizing Antibody Qualitative Rapid Test(colloidal gold) Now with the detection before and after vaccination, TBG''s company has a neutralizing antibody detection reagent, that it can be used as the effective rate detection of antibody before and after vaccination. No matter how the vaccine is administered, The Neutralizing Antibody Qualitative Rapid Test will be used. Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
The second brand in the world health organization test list Colloidal Gold Method This kit applies the principle lateral flow chromatographic immunoassay and uses capture method to detect specific IgM and IgG antibodies against novel coronavirus in human specimens (serum, plasma and venous whole blood).
ExProbeTM SARS-CoV-2 qPCR Testing Kit EU CE Marked, US FDA EUA Approved, Taiwan FDA EUA Approved Intended Use: To detect RdRP/N/E RNA SARS-CoV-2 (COVID-19) in NP/O swabs and sputum. Product Format: 96 tests/kit Kit Contents: PCR Mix, Enzyme Mix, Pos. Control, Neg. Control and Instruction For Use. Storage / Stability: -20C + 5C / 6 months, repeat freeze thaw x 4. Testing kit is compatible for ABI7500,Roche 4800, TBG Q6000 qPCR Systems Reproducibility / Precision 100% Concordant across 3 lots with CV + 5% Limits of Detection (LOD) 50 copies/reaction Performance Comparison* Positive Samples 5 / 5 Negative Samples 199/200
AbChek (SARS-CoV-2) IGM/IGG Corona Rapid Antibody Test Kit Product Details: Number of Reactions(Preps)/Kit : 50 Brand : AbChek ICMR(Govt) Approved : Yes Test Method : (SARS-CoV-2) IgM/IgG Rapid Antibody Result Time (Rapid Kits) : 5-10 minutes Sample Type : Blood Type : Rapid Test Kit Sensitivity : 98 Packaging Size : 50 Tests/ Box Country of Origin : Made in India Corona viruses are enveloped RNA viruses that are distributed broadly among humans, birds and other mammals, that cause respiratory, enteric, hepatic, and neurologic disease. SPECIFICATIONS: Whole blood/serum/plasma may be used for testing. Results available in only 15 minutes. Easy to use. Result can be read visually. No need for an analyser. Cost effective method for assisting in screening COVID-19 disease. Additional Information: Item Code: RapidTestcov19 Production Capacity: 100000 Delivery Time: 10 days Packaging Details: Carton Box
SARS-CoV-19 IgG/IgM test kit (15min showing result) Manufacturer: Guangzhou Wanfo Biotech Co., Ltd. a China listing company Certificates: CE certificate, China NMPA approval (export allowed), no FDA approval The price is $5.5/test (FOB) Max delivered quantity: 100,000/weekly More details please enquire Barry Liu whatsapp: +8617810331113 sample available: 20 test & DHL delivery: $200 Download introductions: https://kdocs.cn/l/sLLC9O6rc
Product Name : COVID-19 SARS-CoV-2 IgM Antibody Test Kit Product Description : Material attachment is good. The shell of the detection card should be flat, the upper and lower covers should be closed evenly, and there should be no obviousgap.Thediluentshouldbeclearandfree offoreignmatter. 1.6 Size:thesizeofteststripshouldnotbelessthan2.5mm. 1.7 Liquidmigrationspeedshouldnotbelessthan10mm/min. 2.Minimumdetectionlimit TheminimumtestlimitreferenceproductsS1shouldbenegative,S2andS3shouldbepositive. 3.Negativecompliancerate 5copiesofnegativereferenceproductsof thetestcompanyshallbeallnegative,withanegativecompliancerateof100%. 4.Positivecompliancerate 5copiesofnegativereferenceproductsof thetestcompanyshallbeallpositive,withanegativecompliancerateof 100%. 5.Repeatability Test1copyoftheenterprisepositivereference,test10times,shouldbeconsistentcolor,arepositive. 6.Specificity 6.4 Cross Reaction: This product with vice influenza virus antibodies, influenza a virus, influenza b virus antibodies, pneumonia chlamydia, mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitisbsurfaceantibody,hepatitis cvirusantibody,treponemapallidumantibody,humanimmunodeficiencyvirus(HIV) antibodies,EBvirusantibody,measlesvirus,CMVantibodies,enterovirustype71,mumpsvirusantibody,varicella - zoster viruspositivesamples nocrossreaction. 6.5 Thereisnocross-reactionbetweenRF,ANAandAMA. 6.6 Interferingsubstance: (3) When bilirubin concentration =250 mol/L, hemoglobin content =9g/L, triglyceride content =15mmol/L,content of rheumatoid factor =80IU/mL, titer ofANA=1:240, anti-mitochondrial antibody (AMA) =80U/mL, content of mouse IgG=1000g/mL,therewillbenointerferencewiththetestresultsof thisproduct. (4) The commonly used antiviral drugs epiztin acid (=4mg/L), ribavirin (=40mg/L), interferon (=200mg/L), oseltamivir (=30mg/L), abidol (=40mg/L), levofloxacin (=200mg/L), azithromycin (=100mg/L), ceftriaxone (=400mg/L), meropenan(=200mg/L) havenointerferenceinthedetectionofthisproduct. 7. Hookeffect No hook effect was found in the test results of this product within the titer range of clinically positive samples of the novel coronavirusantibody. Price of product ( USD price or FOB price) : $4.23 Product origin : China Key Specifications/Special Features : CE FDA Hospital professional testing and use, family and individuals can not use Minimum Order Size and Packgaing details: MOQ:10000pieces 25pieces/box box size:15*14*6.5cm ,150g/box 100boxes /CTN,CTN Size 72*62*36cm 21KG(without lancet and alcohol cotton)
Cat. No : 5513C. COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19
The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C). During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. Theconjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area. If it is a negative sample, there is not a purple-red band appeared in the M and G test area. Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.
The Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) adopts the solid phase colloidal gold immunochromatographic technology for the qualitative determination of IgM/IgG antibodies against SARS-CoV-2
We are manufacturer and supplier of high quality molecular diagnostics product among covid 19 detection kits consisting of: 1]. covid 19/sars cov 2 nucleic acid test kits to detect the covid 19 standard, uk and south africa variants (rt pcr). 2]. covid 19/sars cov 2 antigen rapid test kits. 3]. covid 19/sars cov 2 antibody (igg/igm) rapid test kits. in addition to a product of quality, we offer very competitive price and we have high production capacities to assure a continuous supply of product without shortage..Manufacture, oem
SARS-CoV-2 IgG/IgM Cartridge Kit include : 1 Test Box + 1 Cartridge + 1 UV Touch SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate. Rapid detection of recent SARS-CoV-2 infection In ONLY 12 minutes ONE-STEP operation Single cartridge, NO additional buffers TRFIA Europium particles displays Clear and Bright results Dual capturing antigens (S and N) enhanced sensitivity Important complement to PCR detection in COVID-19 diagnosis
WONDFO SARS-CoV-2 Antibody test kits (Later Flow Method), Rapid response 15 minutes - Easy to use, no equipment required - Multiple sample types, including fingerstick blood - Instant result in 15 minutes - CE marked in vitro diagnostics for professional use in the EU - Measuring IgG/IgM - Specificity 99.57% In Stock Now ready to ship or for inspection 10,000 Test Kits Stockholm 50,000 Test kits in Hong Kong 50,000 Test kits in Jakarta